Trial · NCT03301220
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) as Assessed by the Independent Review Committee (IRC) | From randomization (Day -5) up to 77 months | PFS was defined as the duration from the date of randomization to either progressive to multiple myeloma (MM), according to the International Myeloma Working Group (IMWG) diagnostic criteria for MM, or death due to any cause, whichever occurred first. Per IMWG criteria, active MM by SLiM-CRAB defined as: greater than or equal to (\>=) 60 percent (%) bone marrow plasma cells (BMPCs), free light chain (FLC) involved/uninvolved ratio \>=100, greater than (\>)1 focal bone lesions on magnetic resonance imaging (MRI), calcium elevation, renal insufficiency by creatinine clearance, anemia, or bone disease due to lytic bone lesions. Kaplan-Meier estimate was used. |
| Secondary | Time to Biochemical or Diagnostic (SLiM-CRAB) Progression Per Computerized Algorithm Analyses | From randomization (Day -5) up to 8 years | |
| Secondary | Overall Response Rate (ORR) | From randomization (Day -5) up to 8 years | |
| Secondary | Complete Response (CR) Rate | From randomization (Day -5) up to 8 years | |
| Secondary | Time to First-Line Treatment for Multiple Myeloma | From randomization (Day -5) up to 8 years | |
| Secondary | Progression-Free Survival on First-Line Treatment for Multiple Myeloma (PFS2) | From randomization (Day -5) up to 8 years | |
| Secondary | Best Response on First-line Therapy for Multiple Myeloma | From randomization (Day -5) up to 8 years | |
| Secondary | Overall Survival (OS) | From randomization (Day -5) up to 8 years | |
| Secondary | Percentage of Participants Who Progressed to Multiple Myeloma With Adverse Prognostic Features | From randomization (Day -5) up to 8 years | |
| Secondary | Maximum Observed Serum Concentration (Cmax) of Daratumumab | Cycles 1 and 3 : Day 1 predose, and Day 4 postdose; Cycles 5, 7, 12, and 24: Day 1 predose; end of the treatment (EOT, 37.11 months); and 8 weeks after the last daratumumab dose (up to 38.11 months). Each Cycle was 28 days | |
| Secondary | Minimum Observed Serum Concentration (Cmin) of Daratumumab | Cycles 1 and 3 : Day 1 predose, and Day 4 postdose; Cycles 5, 7, 12, and 24: Day 1 predose; EOT( 37.11 months); and 8 weeks after the last daratumumab dose (up to 38.11 months). Each Cycle was 28 days | |
| Secondary | Number of Participants With Anti-daratumumab Antibodies | Cycles 1 and 3 : Day 1 predose, and Day 4 postdose; Cycles 5, 7, 12, and 24: Day 1 predose; EOT (37.11 months); and 8 weeks after the last daratumumab dose (up to 38.11 months). Each Cycle was 28 days | |
| Secondary | Number of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies | Cycles 1, 3, 5, 7, 12, and 24 : Predose on Day 1; EOT (37.11 months); and 8 weeks after the last daratumumab dose (up to 38.11 months). Each Cycle was 28 days | |
| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score | From Baseline (Day -35) up to 8 years | |
| Secondary | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale | From Baseline (Day -35) up to 8 years | |
| Secondary | Change From Baseline in European Quality (EuroQoL) 5-Dimension 5-Level Health Status (EQ-5D-5L) Questionnaire Score | From Baseline (Day -35) up to 8 years | |
| Secondary | Duration of Response | From randomization (Day -5) up to 8 years | |
| Secondary | Time to Response | From randomization (Day -5) up to 8 years |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03301220/registered